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Avandia News
FDA News
FOR IMMEDIATE RELEASE
P07-88
May 21, 2007
Media Inquiries:
Susan Cruzan, 301-827-6242
Consumer Inquiries:
888-INFO-FDA
FDA Issues Safety Alert on Avandia
The U.S. Food and Drug Administration (FDA) is aware of a
potential safety issue related to Avandia (rosiglitazone),
a drug approved to treat type 2 diabetes. Safety data from
controlled clinical trials have shown that there is a potentially
significant increase in the risk of heart attack and heart-related
deaths in patients taking Avandia. However, other published
and unpublished data from long-term clinical trials of Avandia,
including an interim analysis of data from the RECORD trial
(a large, ongoing, randomized open label trial) and unpublished
reanalyses of data from DREAM (a previously conducted placebo-controlled,
randomized trial) provide contradictory evidence about the
risks in patients treated with Avandia.
Patients who are taking Avandia, especially those who are
known to have underlying heart disease or who are at high
risk of heart attack should talk to their doctor about this
new information as they evaluate the available treatment options
for their type 2 diabetes.
FDA's analyses of all available data are ongoing. FDA has
not confirmed the clinical significance of the reported increased
risk in the context of other studies. Pending questions include
whether the other approved treatment from the same class of
drugs, pioglitazone, has less, the same or greater risks.
Furthermore, there is inherent risk associated with switching
patients with diabetes from one treatment to another even
in the absence of specific risks associated with particular
treatments. For these reasons, FDA is not asking GlaxoSmithKline,
the drug's sponsor, to take any specific action at this time.
FDA is providing this emerging information to prescribers
so that they, and their patients, can make individualized
treatment decisions.
"FDA remains committed to assuring that doctors and
patients have the latest information available to make treatment
and medication use decisions. In this case, FDA is carefully
weighing several complex sources of data, some of which show
conflicting results, related to the risk of heart attack and
heart-related deaths in patients treated with Avandia,"
said Steven Galson, M.D., M.P.H., director of FDA's Center
for Drug Evaluation and Research. "We will complete our
analyses and make the results available as soon as possible.
FDA will take the issue of cardiovascular risk associated
with Avandia and other drugs in this class to an Advisory
Committee as soon as one can be convened."
Avandia was approved in 1999 for treatment of type 2 diabetes,
a serious and life threatening disease that affects about
18 to 20 million Americans. Diabetes is a leading cause of
coronary heart disease, blindness, kidney failure and limb
amputation. Since the drug was approved, FDA has been monitoring
several heart-related adverse events (e.g., fluid retention,
edema and congestive heart failure) based on signals seen
in previous controlled clinical trials of Avandia alone and
in combination with other drugs, and from postmarketing reports.
FDA has updated the product's labeling on several occasions
to reflect these new data, most recently in 2006. The most
recent labeling change for Avandia also included a new warning
about a potential increase in heart attacks and heart-related
chest pain in some individuals using Avandia. This new warning
was based on the result of a controlled clinical trial in
patients with existing congestive heart failure.
Recently, the manufacturer of Avandia provided FDA with a
pooled analysis (meta analysis) of 42 randomized, controlled
clinical trials in which Avandia was compared to either placebo
or other anti-diabetic therapies in patients with type 2 diabetes.
The pooled analysis suggested that patients receiving short-term
(most studies were 6-months duration) treatment with Avandia
may have a 30-40 percent greater risk of heart attack and
other heart-related adverse events than patients treated with
placebo or other anti-diabetic therapy. These data, if confirmed,
would be of significant concern since patients with diabetes
are already at an increased risk of heart disease.
Avandia is manufactured by GlaxoSmithKline, which is based
in Research Triangle Park, N.C.
Alternatives Exist For Patients Taking Avandia
But Doctors Say You Should Consult Your Physician
(KDKA) PITTSBURGH Since the announcement that Avandia, a
popular diabetes drug, could be linked to heart problems,
phones have been ringing off the hook at doctors offices from
concerned patients.
The medicine could lead to a higher risk of heart attack
and possibly even death, according to a study analyzing lots
of studies in the New England Journal of Medicine this week.
Dr. Wayne Evron, an endocrinologist at West Penn Hospital,
has had to explain this to many people taking the drug. "We're
telling them there's a possibility, and if their physician
wants to, they can change their medicine," Evron said.
A wide variety of drugs can treat Type II diabetes. They
work on how sugar and carbohydrates are processed – some
at the muscles, the liver and pancreas. If you take Avandia,
your doctor might switch you to a drug that works at the pancreas
or liver.
There are eight classes of pills for diabetes, along with
insulin, and Avandia is just one pill in one class. You might
be taking one of these others, and right now, there's no need
to worry about them. The study looked specifically at Avandia
only.
Different types of studies need to be done to explain this
link. Possibly, fluid retention with the drug could put people
into congestive heart failure. Also, the medicine could increase
bad cholesterol, a risk factor for heart attack. "Every
time you take a drug, it's risk versus benefit. Every drug
has a risk,” Evron said. “You have to ask the doctor
or yourself, ‘Does the benefit outweigh the risk?’
"
If you’re taking a diabetes drug other than Avandia,
there’s no need to switch medications if you’re
doing OK, KDKA’s Dr. Maria Simbra reports.
Body weight and infertility linked
Penelope Debelle, Adelaide
August 24, 2007 - RESEARCH has confirmed the empirical link between obesity and infertility by showing the "fat eggs" of obese women do not develop into healthy embryos.
The eggs were damaged by high levels of fat and cholesterol, which made diet a key factor in infertility, according to research by PhD student Cadence Minge from the Adelaide University Research Centre for Reproductive Health.
The eggs of female mice, which were fed a high-fat diet that made them insulin-resistant and pre-diabetic, were harvested and grown in vitro but were unable to develop into healthy embryos.
"They were much slower to divide and grow," Ms Minge said. "And the way that the cells developed was also disturbed."
Ms Minge said scientists were yet to understand exactly why the "fat eggs" were infertile and how they were damaged.
But her research had established that a protein in cells that surrounded and nourished the egg was linked to the induced fertility and its effect could be reversed by using an anti-diabetic drug such as rosiglitazone (marketed as Avandia).
The drug activated the protein that helped the egg to mature before its release so that normal embryo development function was restored.
However, Ms Minge said the drug had side effects and was not advocated as "a quick fix" for infertile women.
"The rosiglitazone findings are of great significance for scientists researching egg maturation within the ovary. But at this stage, the research findings have only been made in mice," she said.
"Also, the drug itself can have possible harmful side effects and more research is needed to find other, safer ways of activating the protein."
She said weight loss was by far the most effective way to restore fertility and even shedding five to 10 kilograms was enough to trigger ovulation in obese women who had ceased to ovulate.
"Australia is on a par with heavyweight nations such as the US and the UK, with approximately 60 per cent of Australian adults now overweight or obese," she said. "I hope these findings encourage people to carefully consider the impact of lifestyle choices on longer-term quality of life."
Ms Minge said a strong connection had been known to exist between body weight and infertility but this was the first time a scientific link had been identified.
The next step was to better understand the damage done to the eggs. Microarray techniques were being used in the laboratory to scan for differences in gene expression that would identify genes that were targeted by diet.
Ms Minge said researchers were now collecting and studying the cells of women undergoing IVF treatment.
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